Mindfulness-Oriented Recovery Enhancement (MORE) in Heroin Addiction

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Recruiting

CT.gov ID

NCT04112186

Collaborator

University of Utah (Other), National Center for Complementary and Integrative Health (NCCIH) (NIH)

300

Enrollment

Location

Arms

43.3

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, neuroimaging of reward processing, drug cue reactivity and inhibitory control is used before and immediately after 8 weeks of two types of group therapy in individuals with opioid addiction; clinical outcomes will be assessed before, immediately and three months after treatment. Results could point to factors that track and predict recovery with treatment, offering clinicians markers that can be used for enhancing precision medicine with the goal of reducing morbidity and mortality associated with opiate addiction.

Condition or Disease	Intervention/Treatment	Phase
Opiate Use Disorder	Behavioral: Behavioral group therapy #1 Behavioral: Behavioral group therapy #2	N/A

Detailed Description

Over the past 15 years, the US has been affected by increasing prescription and illicit opiate/opioid abuse, addiction, and overdose. Research into the enhancement of treatment options for individuals with opiate/opioid use disorder (iOUD) is clearly a priority. The development of neuroscience-informed behavioral therapies that could be used as adjuncts to improve effectiveness of medication-assisted interventions in iOUD is a national priority, a response to the opiate crisis. This study measures the neural correlates of cognitive function and reward processing as potentially contributing to and predictive of the impact of an 8-week group therapy on addiction outcome in iOUD. Using a pre-post randomized treatment design with a 3-months follow-up, this study will examine the impact of group therapy, as add-on to methadone maintenance, on neural functional and structural plasticity, and clinical outcomes (including daily ecological momentary assessments), in treatment-seeking iOUD (with primary use of heroin). Treatment-seeking iOUD will be randomized to 8-weeks of one of two of group therapies and scanned with magnetic resonance imaging (MRI) immediately before and after treatment. Healthy controls will be scanned at similar time intervals. Clinical outcome will be assessed during, immediately after and 3-months after therapy. Results may help identify individual variability in the brain regions/circuits that support reward processing, including cue reactivity, and inhibitory control and that could change with, and predict, response to treatment, ultimately contributing to precision medicine in OUD.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Individuals with opiate use disorder (iOUD) will be randomized to one of two 8-weeks of group therapy and scanned with magnetic resonance imaging (MRI) immediately before and after treatment. Functional MRI (fMRI) scans during select tasks and at rest will assess responsiveness and connectivity of neural networks underlying impairments in Response Inhibition and Salience Attribution (iRISA). Structural MRI will assess the morphological integrity of the neural networks. A follow-up visit will take place 3 months after the second MRI scan. Healthy controls will be scanned at similar time intervals. Data collected from healthy control subjects will be used for comparative analyses.Individuals with opiate use disorder (iOUD) will be randomized to one of two 8-weeks of group therapy and scanned with magnetic resonance imaging (MRI) immediately before and after treatment. Functional MRI (fMRI) scans during select tasks and at rest will assess responsiveness and connectivity of neural networks underlying impairments in Response Inhibition and Salience Attribution (iRISA). Structural MRI will assess the morphological integrity of the neural networks. A follow-up visit will take place 3 months after the second MRI scan. Healthy controls will be scanned at similar time intervals. Data collected from healthy control subjects will be used for comparative analyses.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

The PI and the majority of study personnel, including the study statistician, will be blinded to the treatment assignment until the database is unlocked. Assessors (of endpoints) will also be blinded to treatment assignment. That is, treatment allocation will only be known by selected research associates who are not involved in assessment or treatment. The selected research associates who are unblinded will handle randomization and preparation of any unblinded reports (if required); they will not have access to the data and no involvement in data monitoring or analyses.

Primary Purpose:

Treatment

Official Title:

Neuroimaging Response Inhibition and Salience Attribution Changes During Mindfulness-based Treatment of Human Heroin Addiction

Actual Study Start Date :

Oct 21, 2020

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Behavioral group therapy 1 8-weeks of group therapy	Behavioral: Behavioral group therapy #1 Participants will participate in an 8-weeks of group therapy that uses psychological principles including mindfulness training, and could help decrease cravings for heroin and increase general well-being.
Active Comparator: Behavioral group therapy 2 8-weeks of group therapy	Behavioral: Behavioral group therapy #2 Participants will participate in an 8-weeks of group therapy that uses psychological principles (but not including mindfulness training) and could help decrease craving for heroin and increase general well-being.

Arm

Intervention/Treatment

Experimental: Behavioral group therapy 1

8-weeks of group therapy

Behavioral: Behavioral group therapy #1

Participants will participate in an 8-weeks of group therapy that uses psychological principles including mindfulness training, and could help decrease cravings for heroin and increase general well-being.

Active Comparator: Behavioral group therapy 2

8-weeks of group therapy

Behavioral: Behavioral group therapy #2

Participants will participate in an 8-weeks of group therapy that uses psychological principles (but not including mindfulness training) and could help decrease craving for heroin and increase general well-being.

Outcome Measures

Primary Outcome Measures

Change in fMRI BOLD signal during tasks of reward [baseline and 3 months after enrollment]
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during tasks of reward at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI. The reward task uses symbols of gain/win and has been shown to elicit BOLD activations in the brain's reward network.
Change in fMRI BOLD signal for control reactivity [baseline and 3 months enrollment]
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during control reactivity at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI.
Change in fMRI BOLD signal for cue reactivity [baseline and 3 months enrollment]
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during cue reactivity at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI.
Change in fMRI BOLD signal acquired during resting-state functional connectivity [baseline and 3 months after treatment]
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during resting-state functional connectivity at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI. This method captures the synchronicity of low-frequency, spontaneous fluctuations in blood oxygen level-dependent signals that reflect fluctuations in neuronal activity between brain regions in the absence of external stimulation.
Change in MRI Voxel-Based Morphometry (VBM) measure [baseline and 3 months after treatment]
Change in MRI VBM measure for grey matter volume at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI. Voxel Based Morphometry is a whole-brain, fully automated, unbiased, MRI analysis technique used to detect regionally specific differences in brain tissue composition using a voxel-wise comparison across participants.
Change in Urine drug test [baseline and 3 months after treatment]
Urine drug test at 3 months after treatment as compared to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Ability to understand and give informed consent
Males and Females 18-64 years of age
DSM-5 diagnosis of OUD with heroin as the primary drug of choice
Stabilized on methadone or other form of MAT.

Inclusion criteria for healthy controls:

The same as inclusion criteria 1-2 above; dependence on nicotine or caffeine is non-exclusionary.

Exclusion Criteria:

DSM-5 diagnosis for schizophrenia or developmental disorder (e.g., autism)
Head trauma with loss of consciousness
History of neurological disease of central origin including seizures
Cardiovascular disease including high blood pressure and/or other medical conditions, including metabolic, endocrinological,oncological or autoimmune diseases, and infectious diseases common in iOUD including Hepatitis B and C or HIV/AIDS
Metal implants or other MR contraindications

Exclusion criteria for healthy control subjects:

The same, except history of any drug use disorder is prohibitive.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai
University of Utah
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Principal Investigator: Rita Goldstein, PhD, Icahn School of Medicine at Mount Sinai
Study Director: Nelly Alia-Klein, PhD, Icahn School of Medicine at Mount Sinai